Abstract
The present disclosure relates to surgical fastener applying apparatus and the application of variable compression to tissue. More specifically, the presently disclosed surgical fastener applying apparatus act to limit the flow of blood through tissue immediately adjacent a cut-line formed therein to effectuate hemostasis, while maximizing the flow of blood through tissue more removed from the cut-line to limit unnecessary necrosis. In one embodiment, a surgical fastener applying apparatus is disclosed having a tool assembly coupled to a distal end thereof with first and second jaws respectively including an anvil and a surgical fastener cartridge. The surgical fastener cartridge includes, among other things, angled pushers that engage surgical fasteners of varying lengths.
Claims
1. A surgical fastener applying apparatus comprising: an anvil member; a cartridge member coupled to the anvil member, the cartridge member defining a longitudinal axis and including surgical fasteners; a channel located in the cartridge member along the longitudinal axis; and a pusher including a base portion and pusher plates connected to the base portion, the pusher positioned within the cartridge member and repositionable to eject the surgical fasteners from the cartridge member into the anvil member such that two different compressive forces are applied to tissue disposed between the anvil member and the cartridge member, one of the pusher plates being parallel with respect to the channel and another of the pusher plates defining an angle with respect to the channel.
2. The surgical fastener applying apparatus of claim 1, wherein the pusher is of unitary construction.
3. The surgical fastener applying apparatus of claim 1, wherein the pusher and the surgical fasteners are configured and dimensioned such that the compressive forces are varied along an axis transverse to the longitudinal axis.
4. The surgical fastener applying apparatus of claim 1, wherein first and second pusher plates extend from the base portion to define respective first and second lengths, the second length different from the first length.
5. The surgical fastener applying apparatus of claim 1, wherein the pusher plates are interconnected via the base portion.
6. The surgical fastener applying apparatus of claim 1, wherein one of the pusher plates is laterally repositionable relative to channel during movement of the pusher.
7. An end effector for a surgical stapling instrument comprising: an anvil member; and a cartridge member, the cartridge member having: a channel extending along a longitudinal axis of the cartridge member, surgical fasteners disposed in retention slots, a pusher having a base portion with pusher plates extending therefrom, the pusher being movable to urge the surgical fasteners towards the anvil member, wherein adjacent pusher plates define a gap therebetween, the gap varying between a top portion of the adjacent pusher plates and the base portion of the pusher.
8. The end effector of claim 7, further including first and second rows of retention slots.
9. The end effector of claim 8, wherein the anvil member has pockets for receiving legs of the surgical fasteners.
10. The end effector of claim 9, wherein surgical fasteners in the first row of retention slots define a first value of compression upon formation and surgical fasteners in the second rod of retention slots define a second value of compression upon formation that is different from the first value of compression.
11. The end effector of claim 10, wherein the first value of compression is greater than the second value of compression.
12. The end effector of claim 7, wherein the gap between adjacent pusher plates varies as the pusher is moved towards the anvil.
13. The end effector of claim 7, wherein one of the pusher plates defines an acute angle with respect to a tissue contacting surface of the cartridge member.
14. The end effector of claim 7, wherein two pusher plates define two different acute angles with respect to the channel.
15. The end effector of claim 10, wherein the surgical fasteners in the first row of retention slots have a first leg length and the surgical fasteners in the second row of retention slots have a second leg length that is different from the first leg length.
16. The end effector of claim 15, wherein the first leg length is less than the second leg length.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Various embodiments of the present disclosure are described hereinbelow with references to the drawings, wherein:
(2) FIG. 1 is a top, perspective view of a surgical fastener applying apparatus having a tool assembly at a distal end thereof for applying a plurality of surgical fasteners to tissue, according to one embodiment of the present disclosure;
(3) FIG. 2 is a side, perspective view of an exemplary surgical fastener;
(4) FIG. 3 is a partial, perspective view of the tool assembly seen in FIG. 1, with parts separated, illustrating an anvil and a surgical fastener cartridge assembly including a surgical fastener cartridge incorporating angled pushers;
(5) FIG. 4 is a schematic, enlarged view of the area of detail indicated in FIG. 3 illustrating a tissue contacting surface of the anvil and a plurality of fastener pockets formed therein;
(6) FIG. 5 is a longitudinal, cross-sectional view taken along line 5-5 in FIG. 4 illustrating the fastener pockets formed in the tissue contacting surface of the anvil;
(7) FIG. 5A is a lateral, cross-sectional view of an alternative embodiment of the tool assembly seen in FIG. 1 taken through the fastener pockets formed in the anvil and retention slots formed in the surgical fastener cartridge;
(8) FIG. 6 is a lateral, cross-sectional view of the tool assembly seen in FIG. 1 taken through the fastener pockets formed in the anvil and retention slots formed in the surgical fastener cartridge;
(9) FIG. 7 is a side, perspective view of the surgical fastener shown in FIG. 2 exhibiting a standard “B” shaped configuration subsequent to formation through engagement with the fastener pockets formed in the anvil seen in FIG. 3;
(10) FIG. 8 is side, perspective view of a surgical fastener having a single-loop configuration subsequent to formation through contact with the fastener pockets formed in the tissue contacting surface included in an alternative embodiment of the anvil seen in FIG. 3;
(11) FIG. 9A is a side, plan view of one embodiment of the surgical fastener shown in FIG. 2 including legs having a first length and shown prior to formation;
(12) FIG. 9B is a cross-sectional view of the surgical fastener shown in FIG. 9A subsequent to formation within adjacent tissue segments to apply a first compressive force thereto;
(13) FIG. 10A is a side view of another embodiment of the surgical fastener shown in FIG. 2 including legs having a second, shorter length and shown prior to formation;
(14) FIG. 10B is a cross-sectional view of the surgical fastener shown in FIG. 10A subsequent to formation within adjacent tissue segments to apply a second, greater compressive force thereto;
(15) FIG. 11A is a side view of still another embodiment of the surgical fastener shown in FIG. 2 including legs having a third, shorter length and shown prior to formation;
(16) FIG. 11B is a cross-sectional view of the surgical fastener shown in FIG. 11A subsequent to formation within adjacent tissue segments to apply a third, greater compressive force thereto;
(17) FIG. 12 is a partial, longitudinal, perspective view, with parts removed, of the surgical fastener cartridge seen in FIG. 3 illustrating the plurality of surgical fasteners arranged into inner, intermediate, and outer rows;
(18) FIG. 13 illustrates an end-to-end anastomosis device for use with alternative embodiments of the anvil and the surgical fastener cartridge seen in FIG. 3;
(19) FIG. 14 illustrates a surgical fastener applying instrument for use with alternative embodiments of the anvil and the surgical fastener cartridge seen in FIG. 3;
(20) FIG. 15 illustrates a transverse anastomosis fastener applying instrument for use with alternative embodiments of the anvil and the surgical fastener cartridge seen in FIG. 3;
(21) FIG. 16 is a lateral, cross-sectional view of an alternative embodiment of the tool assembly seen in FIG. 1 taken through the fastener pockets formed in the anvil and retention slots formed in the surgical fastener cartridge in accordance with yet another embodiment of the present disclosure;
(22) FIG. 17 is perspective view of a plurality of anvil plates, with parts separated, in accordance with still another embodiment of the present disclosure; and
(23) FIG. 18 is a perspective view of the plurality of anvil plates seen in FIG. 17 after assembly.
DETAILED DESCRIPTION OF THE EMBODIMENTS
(24) Various embodiments of the presently disclosed surgical fastener applying apparatus, and methods of using the same, will now be described in detail with reference to the drawings wherein like references characters identify similar or identical elements. In the drawings, and in the description which follows, the term “proximal” will refer to the end the surgical fastener applying apparatus, or component thereof, that is closest to the clinician during use, while the term “distal” will refer to the end that is furthest from the clinician, as is traditional and conventional in the art. In addition, the term “surgical fastener” should be understood to include any substantially rigid structure that is suitable for the intended purpose of joining tissue together, including but not being limited to surgical staples, clips, and the like.
(25) FIG. 1 illustrates a surgical fastener applying apparatus 1000, of either the re-usable or disposable variety, including a handle assembly 1002, with a movable handle 1003.sub.A and a stationary handle 1003.sub.B, that is operatively connected to a tool assembly 1004 through a distally extending elongated shaft 1006. In various embodiments, the handle assembly 1002 may be manually operated, and either additionally or alternatively, may include motorized, hydraulic, ratcheting, or other such mechanisms. In general, the tool assembly 1004 is adapted to clamp, fasten together, and sever adjacent tissue segments along a cut-line.
(26) Referring now to FIGS. 2-6 as well, the tool assembly 1004 includes a first jaw 1008 that is pivotally coupled to a second jaw 1010 to facilitate approximation thereof. The first jaw 1008 of the tool assembly 1004 includes an anvil 1100, and the second jaw 1010 includes a surgical fastener cartridge assembly 1200 that is loaded with a plurality of surgical fasteners 100 (FIGS. 2, 3). Pivoting the movable handle 1003.sub.A towards the stationary handle 1003.sub.B (FIG. 1) approximates the first jaw 1008 and the second jaw 1010. After the jaws 1008, 1010 are in close operative alignment, continued pivoting of the movable handle 1003.sub.A ejects the plurality of surgical fasteners 100 (FIG. 3) from the surgical fastener cartridge assembly 1200 such that the surgical fasteners 100 are driven into the anvil 1100, thus being formed into completed surgical fasteners, as described in further detail below. The tool assembly 1004 and/or the surgical fastener cartridge assembly 1200 may comprise a removable and replaceable loading unit for the surgical fastener applying apparatus 1000.
(27) As best seen in FIG. 2, each surgical fastener 100 includes two legs 102 that are connected by a backspan 104 extending therebetween. The legs 102 extend from the backspan 104 to penetrating ends 106 to define a length “L” prior to formation. The dimensions of the backspan 106 and the legs 102 can be varied such that the surgical fasteners 100 may be used to fasten tissue having varying attributes, e.g., to fasten tissue of varying thickness, and/or to accommodate the presence of scar tissue. The dimensions of the legs 102 and the backspan 104 can be varied such that the surgical fasteners 100 can apply varying amounts of pressure to tissue.
(28) The legs 102 and the backspan 104 may define a cross-section having any suitable geometric configuration including, but not limited to, rectangular, oval, square, triangular, trapezoidal, etc. The legs 102 and the backspan 104 may exhibit the same geometrical configuration, as shown in FIG. 2, or alternatively, the legs 102 and the backspan 104 may exhibit different geometrical configurations. For example, the legs 102 may exhibit a rectangular cross-section, whereas the backspan 104 may exhibit an oval cross-section.
(29) The penetrating ends 106 of the legs 102 may be tapered to facilitate the penetration of tissue, or alternatively, the penetrating ends 106 may not include a taper. In various embodiments, it is also envisioned that the penetrating ends 108, 110 may define either a conical surface, or a flat surface.
(30) Prior to formation, the legs 102 of each surgical fastener 100 may extend from the backspan 104 such that they are substantially parallel. In the alternative, the legs 102 may converge or diverge from the backspan 104.
(31) Referring now to FIG. 3 in particular, the surgical fastener applying apparatus 1000 also includes a knife member 1007 that is operatively connected to a drive beam 1012, as described in commonly assigned U.S. Pat. No. 7,398,908, currently assigned to Tyco Healthcare Group LP, the contents of which are hereby incorporated by reference herein in its entirety, and discussed in further detail below. The knife member 1007 may be configured and dimensioned for simultaneous engagement with both the anvil member 1100 and a cavity 1222 that is defined by the second jaw 1010.
(32) During use, the tool assembly 1004 is first actuated to clamp onto tissue by manipulating the movable handle 1003.sub.A to advance a control rod (not shown) distally. Distal advancement of the control rod results in corresponding movement of the knife member 1007, and effectuates approximation of the anvil member 1100 and the surgical fastener cartridge assembly 1200. With tissue clamped between the anvil member 1100 and the surgical fastener cartridge assembly 1200, the fasteners 100 (FIGS. 2, 3) are fired from the surgical fastener applying apparatus 1000 (FIG. 1) into the tissue. The movable handle 1003.sub.A is then operated again to further advance the knife member 1007.
(33) Referring now to FIGS. 3-6, the anvil 1100 and the surgical fastener cartridge assembly 1200 of the tool assembly 1004 (FIG. 1) will be discussed in further detail. The anvil 1100 is an elongated member having a tissue contacting surface 1102 with a plurality of pockets 1104 (FIG. 4) formed therein. Each of the pockets 1104 is positioned to receive the legs 102 (FIG. 2) of the surgical fastener 100, and is configured to redirect the legs 102 to thereby form the surgical fasteners 100. More particularly, in the embodiment of the anvil 1100 seen in FIGS. 3-6, each pocket 1104 includes two forming surfaces 1106, 1108 (FIGS. 4, 5) that extend into the anvil 1100, i.e., away from the tissue contacting surface 1102, to define a depth ‘D” (FIG. 5). Upon engagement of the legs 102 (FIG. 2) with the forming surfaces 1106, 1108, the forming surfaces 1106, 1108 guide the legs 102 inwardly in the direction of arrows “A” (FIG. 4) to facilitate deformation of the surgical faster 100 into the standard “B” shaped configuration (FIG. 7). In an alternative embodiment, the anvil 1100 may include pockets 1104 that are configured and dimensioned to deform the surgical fastener 100 such that the surgical fastener 100 defines a single-loop configuration (FIG. 8) upon formation. It is also envisioned that the surgical fastener 100 may exhibit other configurations upon formation.
(34) The pockets 1104 are arranged into rows disposed on opposite sides of a slot 1110 extending at least partially through the anvil member 1100 (FIGS. 3, 4). The slot 1110 is configured to accommodate longitudinal movement of the knife member 1007 (FIG. 3) such that tissue may be severed along a cut-line. Although the slot 1110 is depicted as extending longitudinally through the anvil 1100, in alternative embodiments, the slot 1110 may define a configuration that is angled, arcuate, or shaped otherwise. The slot 1110 may extend along a centerline of the anvil 1100, as shown in the embodiment illustrated in FIGS. 3 and 4, or alternatively, the slot 1110 may be spaced therefrom.
(35) In the specific embodiment of the anvil 1100 seen in FIGS. 3-6, the pockets 1104 are arranged into a pair of outer rows 1112.sub.A (FIG. 4) that are spaced laterally outward of the slot 1110 and furthest therefrom, a pair of intermediate rows 1112.sub.B that are spaced laterally inward of the pair of outer rows 1112.sub.A, and a pair of inner rows 1112.sub.C that are spaced laterally inward of the pair of intermediate rows 1112.sub.B and closest to the slot 1110. While the anvil 1100 is depicted as including three rows of pockets 1104, i.e., the respective outer, intermediate, and inner rows 1112.sub.A, 1112.sub.B, 1112.sub.C, the arrangement of pockets 1104 into fewer or greater numbers of rows in alternative embodiments is also within the scope of the present disclosure. With reference to FIG. 5A, in one particular embodiment, the anvil 1100 includes additional rows of pockets 1104 to accommodate for any lateral deflection experienced by the surgical fasteners 100, i.e., towards or away from the slot 1110, as they are deployed through the tissue grasped between the jaws 1008, 1010 (FIG. 1) of the tool assembly 1004. The surgical fasteners 100 may be deflected laterally, for example, due to the presence of scar tissue, irregularities in the tissue, or tissue of increased thickness. By providing additional rows of pockets 1104, the likelihood of engagement between the surgical fasteners 100 and one of the pockets 1104, and thus, proper fastener formation, is increased.
(36) With continued reference to FIGS. 3-6, the surgical fastener cartridge assembly 1200 will be discussed. In the particular embodiment seen in FIGS. 3 and 6, the surgical fastener cartridge assembly 1200 is loaded with three varieties of surgical fastener, i.e., the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C seen in FIGS. 9A-11B. In alternative embodiments, however, the surgical fastener cartridge assembly 1200 may include fewer or additional varieties of surgical fasteners 100.
(37) Turning momentarily to FIGS. 9A-11B, it can be seen that the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C are substantially identical but for the respective lengths “L.sub.A,” “L.sub.B,” “L.sub.C” defined by their legs 102.sub.A, 102.sub.B, 102.sub.C. Specifically, the length “L.sub.B” defined by the legs 102.sub.B of the surgical fasteners 100.sub.B is less than the length “L.sub.A” defined by the legs 102.sub.A of the surgical fasteners 100.sub.A, and the length “L.sub.C” defined by the legs 102.sub.C of the surgical fasteners 100.sub.C is less than the length “L.sub.B” defined by the legs 102.sub.B of the surgical fasteners 100.sub.B. Stated differently, the surgical fasteners 100.sub.C have the shortest legs 102.sub.C, and the surgical fasteners 100.sub.A have the longest legs 102.sub.A.
(38) As seen in FIGS. 3 and 6, the surgical fastener cartridge assembly 1200 includes a surgical fastener cartridge body 1202 extending along an axis “X-X” (FIG. 3) that houses, among other components, the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C (FIGS. 9A-11B). A longitudinal slot 1204 extends through the surgical fastener cartridge body 1202 that is configured and dimensioned to accommodate longitudinal movement of the knife 1007 (FIG. 3) such that tissue may be severed along the aforementioned cut-line. Although the slot 1204 is depicted as extending longitudinally through the surgical fastener cartridge body 1202, in alternative embodiments, the slot 1204 may define a configuration that is angled, arcuate, or shaped otherwise. The slot 1204 may extend along a centerline of the surgical fastener cartridge body 1202, as shown in the embodiment illustrated in FIGS. 3 and 6, or alternatively, the slot 1204 may be spaced therefrom.
(39) The surgical fastener cartridge body 1202 is defined by a substantially planar bottom wall 1206, a pair of side walls 1208, 1210 that extend upwardly therefrom, and a top wall 1212. The top wall 1212 is also substantially planar, and extends in substantially parallel relation to the bottom wall 1206. The top wall 1212 includes a tissue engaging surface 1214, e.g., for maintaining the position of the tissue to be cut. When the jaws 1008, 1010 (FIG. 1) of the tool assembly 1004 are in an approximated position, the tissue engaging surface 1214 of the top wall 1212 is spaced a distance “Y” (FIG. 6) from the tissue contacting surface 1102 of the anvil 1100.
(40) The tissue engaging surface 1214 of the top wall 1212 further includes a plurality of fastener retention slots 1216 formed therein. Each fastener retention slot 1216 is configured and dimensioned to receive one of the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C (FIGS. 6, 9A-11B). To drive the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C upwardly, i.e., towards the top wall 1212, and through the fastener retention slots 1216, the surgical fastener cartridge assembly 1200 further includes a plurality of pushers 1218 (FIG. 3) and a sled 1220 that is disposed within the cavity 1222 defined by the second jaw 1010 of the tool assembly 1004 (FIG. 1).
(41) The pushers 1218 are positioned beneath the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C, and are configured to engage the sled 1220 as the sled 1220 traverses the cavity 1222 via translation of the drive beam 1012, or other such actuation component. Each pusher 1218 includes a plurality of pusher plates, identified generally by the reference character 1224, corresponding in number to the number of rows of fastener lines desired within the tissue upon firing of the surgical fastener applying apparatus 1000 (FIG. 1). Accordingly, in the embodiment seen in FIGS. 3 and 5, each pusher 1218 includes three pusher plates, i.e., outer, intermediate, and inner pusher plates 1224.sub.A, 1224.sub.B, 1224.sub.C, respectively. In alternative embodiments, however, it is envisioned that the pushers 1218 may include fewer or greater numbers of pusher plates 1224 should the desired number of rows of fastener lines be fewer or greater.
(42) Each of the respective outer, intermediate, and inner pusher plates 1224.sub.A, 1224.sub.B, 1224.sub.C extends upwardly from, and is connected to, a base portion 1226 of the pusher 1218 at one or more hinge members 1228. In one embodiment, as seen in FIG. 6 for example, the hinge member(s) 1228 may comprise a living hinge formed integrally with the pusher 1218. The hinge member(s) 1228 permit the outer, intermediate, and inner pusher plates 1224.sub.A, 1224.sub.B, 1224.sub.C to diverge as the pushers 1218 are driven upwardly by the sled 1220 (FIG. 3). The outer, intermediate, and inner pusher plates 1224.sub.A, 1224.sub.B, 1224.sub.C extend from the base portion 1226 in offset relation such that the outer pusher plate 1224.sub.A and the intermediate pusher plate 1224.sub.B subtend a first acute angle θ.sub.1, while the intermediate pusher plate 1224.sub.B and the outer pusher plate 1224.sub.C subtend a second acute angle θ.sub.2.
(43) In one particular embodiment, the pushers 1218 are unitary in construction, as shown in FIG. 6 for example, such that the pusher plates 1224 extend directly from the base portion 1226. For example, it is envisioned that the pusher plates 1224 may be integrally, e.g., monolithically, formed with the base portion 1226. It is also envisioned, however, that the pushers 1218 and the pusher plates 1224 may constitute separate, discrete structures.
(44) The outer, intermediate, and inner pusher plates 1224.sub.A, 1224.sub.B, 1224.sub.C are configured and dimensioned to engage the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C, respectively. Consequently, the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C are also arranged within the surgical fastener cartridge body 1202 in offset relation such that the surgical fasteners 100.sub.A, 100.sub.B subtend the first acute angle θ.sub.1 and the surgical fasteners 100.sub.B, 100.sub.C subtend the second acute angle θ.sub.2.
(45) The distance “D” measured from the pushers 1218 to the tissue contacting surface 1102 of the anvil 1100 for each of the pushers 1218 is substantially the same. While the height of each pusher 1218, measured along the vertical axis “Z-Z,” or height, of the surgical fastener cartridge 1200 is substantially the same, the offset relationship between the respective outer, intermediate, and inner pusher plates 1224.sub.A, 1224.sub.B, 1224.sub.C results in each pusher plate defining a different length. More specifically, in the embodiment seen in FIG. 6, the outer pusher plate 1224.sub.A defines a greater length than the intermediate pusher plate 1224.sub.B, and the intermediate pusher plate 1224.sub.B defines a greater length than the inner pusher plate 1224.sub.C. Stated differently, the pushers 1218 are arranged beneath the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C such that shortest pusher plate, i.e., inner pusher plate 1224.sub.C, is disposed closest to the slot 1204 and beneath the shortest surgical fastener, i.e., the surgical fastener 100.sub.A, and the longest pusher plate, i.e., the outer pusher plate 1224.sub.A, is disposed furthest from the slot 1204 and beneath the longest surgical fastener, i.e., the surgical fasteners 100.sub.C.
(46) The offset relationship between the respective outer, intermediate, and inner pusher plates 1224.sub.A, 1224.sub.B, 1224.sub.C, and the corresponding offset relationship between the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C, results in the definition of a variable distance between the respective penetrating ends 106.sub.A, 106.sub.B, 106.sub.C of the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C and the pockets 1104 formed in the tissue contacting surface 1102 of the anvil 1100. More specifically, the penetrating ends 106.sub.A of the surgical fasteners 100.sub.A are spaced a distance “X.sub.A” from the pockets 1104 comprising the pair of outer rows 1112.sub.A (FIG. 4), the penetrating ends 106.sub.B of the surgical fasteners 100.sub.B are spaced a distance “X.sub.B” from the pockets 1104 comprising the intermediate pair of rows 1112.sub.B, and the penetrating ends 106.sub.C of the surgical fasteners 100.sub.C are spaced a distance “X.sub.C” from the pockets 1104 comprising the inner pair of rows 1112.sub.C. In the illustrated embodiment, the distance ‘X.sub.A” is less than the distance “X.sub.B,” and the distance “X.sub.B” is less than the distance “X.sub.C.”
(47) The fastener retention slots 1216 are arranged into pairs of outer, intermediate, and inner rows 1230.sub.A, 1230.sub.B, 1230.sub.C (FIG. 3) that correspond respectively to the pairs of outer, intermediate, and inner rows 1112.sub.A, 1112.sub.B, 1112.sub.C (FIG. 4) of pockets 1104 formed in the tissue contacting surface 1102 of the anvil 1100, thus increasing the likelihood of proper engagement between the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C and the pockets 1104. Accordingly, upon ejection of the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C from the fastener retention slots 1216, the surgical fasteners 100.sub.A are directed into contact with the pockets 1104 comprising the pair of outer rows 1112.sub.A, the surgical fasteners 100.sub.B are directed into contact with the pockets 1104 comprising the pair of intermediate rows 1112.sub.B, and the surgical fasteners 100.sub.C are directed into contact with the pockets 1104 comprising the pair inner of rows 1112.sub.C. In one embodiment, as seen in FIG. 6, the fastener retention slots 1216 comprising the pairs of outer, intermediate, and inner rows 1230.sub.A, 1230.sub.B, 1230.sub.C may be connected at lead-ins 1232, which may be radiused, as shown, or of any other suitable configuration, e.g., planar or pointed. Alternatively, however, it is envisioned that the fastener retention slots 1216 comprising the respective outer, intermediate, and inner pairs of rows 1230.sub.A, 1230.sub.B, 1230.sub.C may be discrete.
(48) The pair of outer rows 1230.sub.A (FIGS. 3, 6) of fastener retention slots 1216 are spaced laterally outward of the slot 1204 and are disposed furthest therefrom, the pair of intermediate rows 1230.sub.B are spaced inwardly of the pair of outer rows 1230.sub.A, and the pair of inner rows 1230.sub.C are spaced inwardly of the pair of intermediate rows 1230.sub.B and are disposed closest to the slot 1204, each of the respective inner, intermediate, and outer pairs of rows 1230.sub.A, 1230.sub.B, 1230.sub.C being arranged on opposite sides of the slot 1204. Consequently, as the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C exit the fastener retention slots 1216 and are formed within tissue, the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C will be arranged to respectively define outer, intermediate, and inner fastener lines on opposite sides of the cut-line formed in the tissue. While the surgical fastener cartridge body 1202 is depicted as including three pairs of rows, i.e., the respective outer, intermediate, and inner rows 1230.sub.A, 1230.sub.B, 1230.sub.C, fewer and greater numbers of rows of fastener retention slots 1216 may be included in alternative embodiments of the surgical fastener cartridge assembly 1200.
(49) With reference again to FIGS. 9A-9B, the surgical fasteners 100.sub.A will be discussed before and after formation. As seen in FIG. 9A, before formation, the legs 102.sub.A of the surgical fastener 100.sub.A define a length “L.sub.A” that is measured from the penetrating ends 106.sub.A to an outer surface 108.sub.A of the backspan 104.sub.A. After formation, the legs 102.sub.A are configured such that the surgical fastener 100.sub.A defines, for example, the standard “B” shaped configuration (FIG. 9B). When formed within adjacent tissue segments “T.sub.1,” “T.sub.2,” the tissue segments “T.sub.1,” “T.sub.2” are compressed and maintained in approximation between an inner surface 110.sub.A of the curved legs 102.sub.A and an inner surface 112.sub.A of the backspan 104.sub.A within a compressive space 114.sub.A. The compression of the tissue segments “T.sub.1,” “T.sub.2” creates a biasing force “B.sub.A” in the tissue segments “T.sub.1,” “T.sub.2” that endeavors to force the legs 102.sub.A of the surgical fastener 100.sub.A outwardly in the direction indicated by arrows 1. The legs 102.sub.A resist yielding, but their length “L.sub.A” allows the legs 102.sub.A to be deflected outwardly, albeit a minimal distance, under the influence of the biasing force “B.sub.A” such that the compressive space 114.sub.A ultimately defines a dimension “C.sub.A.” Maintaining the tissue segments “T.sub.1,” “T.sub.2” within the compressive space 114.sub.A subjects the tissue segments “T.sub.1,” “T.sub.2” to a corresponding compressive force “F.sub.A” which limits, but does not completely restrict, the flow of blood through the tissue surrounding the surgical fastener 100.sub.A. Thus, unnecessary necrosing of the fastened tissue segments “T.sub.1,” “T.sub.2” may be prevented or impeded.
(50) With reference now to FIGS. 10A-10B, the surgical fastener 100.sub.B is shown before and after formation, respectively. Before formation, the legs 102.sub.B define a length “L.sub.B” that is measured from the penetrating ends 106.sub.B to the outer surface 108.sub.B of the backspan 104.sub.B. The length “L.sub.B” is less than the length “L.sub.A” defined by the legs 102.sub.A of the surgical fastener 100.sub.A illustrated in FIGS. 9A-9B. After formation, the legs 102.sub.B are configured such that the surgical fastener 100.sub.B also defines the standard “B” shaped configuration (FIG. 10B). When the surgical fastener 100.sub.B is formed within tissue segments “T.sub.1,” “T.sub.2,” the compressed tissue segments “T.sub.1,” “T.sub.2” exert a biasing force “B.sub.B” that endeavors to force the legs 102.sub.B outwardly in the direction indicated by arrows 1. The shorter length “L.sub.B” of the legs 102.sub.B allows the legs 102.sub.B to resist yielding to a greater extent than the legs 102.sub.A of the surgical fastener 100.sub.A such that a compressive space 114.sub.B is ultimately defined with a dimension “C.sub.B” that is smaller in comparison to the dimension “C.sub.A” of the compressive space 114.sub.A illustrated in FIG. 9B. The smaller dimension “C.sub.B” of the compressive space 114.sub.B results in the application of a corresponding compressive force “F.sub.B” to the tissue segments “T.sub.1,” “T.sub.2” that is greater than the compressive force “F.sub.A” applied by the surgical fastener 100.sub.A. Consequently, the flow of blood through the tissue surrounding the surgical fastener 100.sub.B is further restricted when compared to the flow of blood through the tissue surrounding the surgical fastener 100.sub.A, thereby further facilitating hemostasis. The compressive force “F.sub.B” does not completely restrict the flow of blood through the tissue surrounding the surgical fastener 100.sub.B, however. Thus, unnecessary necrosing of the fastened tissue segments “T.sub.1,” “T.sub.2” may be prevented or impeded.
(51) FIGS. 11A-11B illustrate the surgical fastener 100.sub.C before and after formation, respectively. Before formation, the legs 102.sub.C define a length “L.sub.C” that is measured from the penetrating ends 106.sub.C to the outer surface 108.sub.C of the backspan 104.sub.C. The length “L.sub.C” is less than the length “L.sub.B” defined by the legs 102.sub.B of the surgical fastener 100.sub.B illustrated in FIGS. 10A-10B. After formation, the legs 102.sub.C are configured such that the surgical fastener 100.sub.C also defines the standard “B” shaped configuration (FIG. 11B). When the surgical fastener 100.sub.C is formed within tissue segments “T.sub.1,” “T.sub.2,” the compressed tissue segments “T.sub.1,” “T.sub.2” exert a biasing force “B.sub.C” that endeavors to force the legs 102.sub.C outwardly in the direction indicated by arrows 1. The shorter length “L.sub.C” of the legs 102.sub.C allows the legs 102.sub.C to resist yielding to a greater extent than the legs the legs 102.sub.B of the surgical fastener 100.sub.B such that a compressive space 114.sub.C is ultimately defined with a dimension “C.sub.C” that is smaller in comparison to the dimension “C.sub.B” of the compressive space 114.sub.B illustrated in FIG. 10B. The smaller dimension “C.sub.C” of the compressive space 114.sub.C results in the application of a corresponding compressive force “F.sub.C” to the tissue segments “T.sub.1,” “T.sub.2” that is greater than the compressive force “F.sub.B” applied by the surgical fastener 100.sub.B. Consequently, the flow of blood through the tissue surrounding the surgical fastener 100.sub.C is further restricted when compared to the flow of blood through the tissue surrounding the surgical fastener 100.sub.B. The compressive force “F.sub.B” applied to the tissue segments “T.sub.1,” “T.sub.2” substantially, if not completely restricts the flow of blood through the tissue surrounding the surgical fastener 100.sub.C, thereby further facilitating, and effectuating hemostasis.
(52) The length “L.sub.A” of the legs 102.sub.A, the length “L.sub.B” of the legs 102.sub.B, and the length “L.sub.C” of the legs 102.sub.C, as well as the corresponding dimensions “C.sub.A,” “C.sub.B,” “C.sub.C” of the compressive spaces 114.sub.A, 114.sub.B, 114.sub.C occupied by tissue segments “T.sub.1,” “T.sub.2” when the respective surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C are in their formed conditions, may be altered or varied in different embodiments of the present disclosure to effectuate any desired level of hemostasis and blood flow in the tissue segments “T.sub.1,” “T.sub.2.” Furthermore, the size of the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C may be substantially the same, or may vary within a row of retention slots 1216, or in any other pattern.
(53) Referring now to FIGS. 6 and 12, the pushers 1218 are arranged longitudinally on opposite sides of the slot 1204 extending through the surgical fastener cartridge body 1202 such that the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C define pairs of outer, intermediate, and inner rows 1234.sub.A, 1234.sub.B, 1234.sub.C that correspond respectively in position to the outer, intermediate, and inner rows 1230.sub.A, 1230.sub.B, 1230.sub.C (FIG. 3) of fastener retention slots 1216. Accordingly, the surgical fasteners 100.sub.A comprising the pair of outer rows 1234.sub.A will be spaced laterally outward, and furthest from, the cut-line formed upon fastening, the surgical fasteners 100.sub.B comprising the pair of intermediate rows 1234.sub.B will be disposed inwardly of the surgical fasteners 100.sub.A comprising the pair of outer rows 1234.sub.A, and the fasteners 100.sub.C comprising the pair of inner rows 1234.sub.C will be disposed inwardly of the surgical fasteners 100.sub.B comprising the pair of intermediate rows 1234.sub.B, along the cut-line, and closest thereto. The respective outer, intermediate, and inner rows 1234.sub.A, 1234.sub.B, 1234.sub.C of surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C will be applied to the tissue such that they define corresponding lines of fasteners on opposite sides of the cut-line.
(54) The surgical fastener cartridge body 1202 seen in FIGS. 3, 6, and 12 is illustrated as including outer, intermediate, and inner rows 1234.sub.A, 1234.sub.B, 1234.sub.C exclusively including the respective surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C. In other words, each surgical fastener disposed in a particular row will have the same configuration, i.e., legs of the same length. By arranging the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C in this manner, the surgical fasteners with the shortest leg length resulting in the greatest compressive force, i.e., surgical fasteners 100.sub.C, are deployed closest to the cut-line, and the surgical fasteners having longer legs and resulting in lesser compressive forces, i.e., surgical fasteners 100.sub.A and 100.sub.B, are provided further from the cut-line. Consequently, arranging the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C in this way minimizes the flow of blood through the tissue immediately adjacent the cut-line and gradually increases the flow of blood through the tissue spaced a greater lateral distance therefrom. It should be appreciated that the length of the legs could be varied to accommodate tissue of different thicknesses and to control tissue compression by the fasteners 100.sub.A, 100.sub.B, 100.sub.C.
(55) In alternative embodiments of the present disclosure, it is envisioned that the surgical fastener cartridge body 1202 may include outer, intermediate, and inner rows 1234.sub.A, 1234.sub.B, 1234.sub.C comprising a combination of surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C such that a particular row may include a variety of surgical fasteners having different configurations, e.g., legs of different lengths. By providing a variety of surgical fasteners in each row, the flow of blood through the tissue can be controlled longitudinally, along the cut-line, as well laterally as the distance therefrom is varied.
(56) With continued reference to FIG. 12, by loading the surgical fastener cartridge 1200 (FIG. 3) with a variety of surgical fasteners, e.g., surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C, and by arranging the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C such that those with the shortest legs, i.e., surgical fasteners 100.sub.C, are closest to the cut-line and those with the longest legs, i.e., surgical fasteners 100.sub.A, are furthest from the cut-line, a greater range of tissue thickness can be effectively fastened, as the thickness of the tissue will generally increase with the distance from the cut-line, e.g., as a result of clamping by the tool assembly 1004 (FIG. 1). Accordingly, loading the surgical fastener cartridge 1200 with a variety of surgical fasteners having legs of various lengths allows a single surgical fastener cartridge 1200 to fasten tissue of varying thickness.
(57) Referring now to FIGS. 1-6 and 9-12, a method of fastening tissue with the surgical fastener applying apparatus 1000 (FIG. 1) will be discussed. During use, the surgical fastener applying apparatus 1000 is approximated and fired similarly to, and in accordance with other known surgical fastener applying apparatus, such as that disclosed in commonly assigned U.S. Pat. No. 5,865,361, currently assigned to Tyco Healthcare Group LP, the contents of which are hereby incorporated by reference herein in its entirety.
(58) The movable handle 1003.sub.A is operatively connected to an actuation shaft, which receives the proximal end of a control rod, such that manipulation of the movable handle 1003.sub.A results in linear advancement of the actuation shaft, which causes corresponding linear advancement of the control rod. An axial drive assembly is also provided that is engagable with the control rod. More specifically, the axial drive assembly includes the elongated drive beam 1012 (FIG. 3), which includes a distal end that supports the knife blade 1007, and a drive member that is configured and dimensioned for engagement with the control rod. As seen in FIG. 3, the knife 1007 is positioned to translate behind the sled 1220.
(59) After the surgical fastener applying apparatus 1000 (FIG. 1) is manipulated to position the target tissue between the open jaws 1008, 1010 (FIG. 1) of the tool assembly 1004, the jaws 1008, 1010 are approximated using the handle assembly 1002 to clamp the target tissue therebetween and apply a compressive force thereto. Specifically, manipulation of the movable handle 1003.sub.A advances the actuation shaft to effectuate corresponding advancement of the control rod. Since the control rod is connected at its distal end to the drive assembly, which includes the aforementioned drive beam 1113, distal movement of the control rod causes corresponding movement of the drive beam 1113, which in turn, forces the anvil 1100 towards the surgical fastener cartridge assembly 1200.
(60) With the tissue securely clamped between the jaws 1008, 1010 (FIG. 1), the surgical fastener applying apparatus 1000 is then fired to eject the surgical fasteners, e.g., the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C (FIGS. 9A-11B). To fire the surgical fastener applying apparatus 1000, the movable handle 1003.sub.A is again manipulated to cause advancement of the drive assembly, which causes the sled 1220 (FIG. 3) to traverse the cartridge body 1202, and eject the plurality of surgical fasteners 100 from the surgical fastener cartridge assembly 1200. More specifically, as the sled 1220 moves distally, it engages the pushers 1218 (FIGS. 3, 6) to thereby drive the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C upwardly, i.e., towards the top wall 1212 of the surgical fastener cartridge body 1202. As the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C are driven upwardly, the fastener retention slots 1216 (FIGS. 3, 6) maintain the relative positions thereof.
(61) After passing through the fastener retention slots 1216, the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C pass through the tissue and are forced into engagement with the pockets 1104 formed in the tissue contacting surface 1102 of the anvil 1100, thereby achieving, for example, the formed configurations seen in FIGS. 9B, 10B, and 11B, respectively. Upon formation within the tissue, the surgical fasteners 100.sub.A, 100.sub.B, 100.sub.C limit the blood flow through the tissue immediately adjacent and surrounding the cut-line to thereby effectuate hemostasis, while permitting greater blood flow through the tissue spaced laterally therefrom to minimizing necrosing of the tissue, as discussed above.
(62) While the tool assembly 1004 (FIG. 1) has been discussed in connection with the surgical fastener applying apparatus 1000, which is adapted for use in laparoscopic procedures for performing surgical anastomotic fastening of tissue, the tool assembly 1004 may be adapted for use with any surgical instrument suitable for the intended purpose of applying the plurality of surgical fasteners, e.g., the surgical fasteners 100 (FIG. 2), the surgical fasteners 100.sub.A (FIGS. 9A, 9B), the surgical fasteners 100.sub.B (FIGS. 10A, 10B), and/or the surgical fasteners 100.sub.C (FIGS. 11A, 11B), to a section of tissue, and thereafter, severing the tissue along a cut-line.
(63) For example, the tool assembly 1004 (FIG. 1) may be adapted for use with an end-to-end anastomosis (EEA) apparatus 2000 (FIG. 10), such as that disclosed in commonly assigned U.S. Pat. No. 7,455,676, currently assigned to Tyco Healthcare Group LP, the contents of which are hereby incorporated by reference herein in its entirety. The EEA apparatus 2000 includes a handle assembly 2002 having at least one pivotable actuating handle member 2004, and advancing means 2006. Extending from handle assembly 2002, there is provided a tubular body portion 2008 that terminates in a fastener ejection (tool) assembly 2010 having a circular fastener cartridge 2012 that is configured and dimensioned to retain a plurality of surgical fasteners therein. An anvil shaft 2014 operatively couples an anvil assembly 2016 to the handle assembly 2002 such that the anvil assembly 2016 is repositionable from a location where it is in close cooperative alignment with the fastener cartridge 2012 to a location where it is spaced apart from the fastener staple cartridge 2012.
(64) The tool assembly 2010 includes a fastener ejection member that is positioned within the fastener cartridge 2012. The fastener ejection member includes a distal portion defining concentric rings of peripherally spaced staple pushers that are received within a respective staple retention slot to eject the surgical fasteners from the fastener cartridge 2012. The fastener ejection member is configured and dimensioned to be contacted by a distal end of a driver tube that is operatively connected to the advancing means 2006 through the body portion 2008 such that manipulation of the advancing means effectuates advancement of the driver tube to force the staple pushers into engagement with the plurality of surgical fasteners retained with in the fastener cartridge 2012 to causes ejection thereof.
(65) The tool assembly 1004 (FIG. 1) may also be adapted for use with a surgical stapling apparatus 3000 (FIG. 11), such as that disclosed in commonly assigned U.S. Pat. No. 7,334,717, currently assigned to Tyco Healthcare Group LP, the contents of which are hereby incorporated by reference herein in its entirety. The surgical stapling apparatus 3000 includes a cartridge receiving half-section 3002, which accommodates a plurality of surgical fasteners, and an anvil half-section 3004. The half-sections 3002, 3004 are pivotally connected via handles 3006, 3008 for approximation during use.
(66) Following approximation of the half-sections 3002, 3004, the surgical fastener applying apparatus 3000 is fired by driving a firing slide 3010 distally through the advancement of a firing lever 3012. Distal movement of the firing slide 3010 causes a plurality of cam bars to engage camming surfaces that interact with a plurality of pushers to expel the plurality of surgical fasteners from the cartridge receiving half-section 3002. The surgical fasteners are positioned on either side of a track which guides a knife during longitudinal movement to thereby sever tissue along a cut-line.
(67) The tool assembly 1004 (FIG. 1) may also be adapted for use with a transverse anastomosis fastening instrument 4000 (FIG. 12), such as that disclosed in commonly owned U.S. Pat. No. 5,964,394, currently assigned to United States Surgical Corporation, the contents of which are hereby incorporated by reference herein in its entirety. The surgical fastener applying apparatus 4000 includes an approximation lever 4001, a movable handle 4002, an elongated portion 4004 that extends distally from the handle 4002, and an arm 4006 that extends from a distal end 4008 of the elongated portion 4004. The surgical fastener applying apparatus 4000 further includes a tool assembly 4010 that includes an anvil 4012 that is orthogonally affixed to the arm 4006, and a surgical fastener cartridge receiver 4014 that is operatively coupled to the distal end 4008 of the elongated portion 4004 for retention of the surgical fastener cartridge 200.
(68) Prior to firing of the surgical fastener applying apparatus 4000, the approximation lever 4001 is actuated to distally advance a drive member that is operatively connected to the surgical fastener cartridge 200 to move the surgical fastener cartridge 200 towards the anvil 4012, which remains stationary, and capture tissue therebetween. Thereafter, the handle 4002 is moved to advance a pusher bar distally through the elongated portion 4004 to cause corresponding movement of a head portion included at the distal end of the pusher bar. The head portion includes a plurality of fingers extending distally therefrom that are configured and dimensioned to engage the cartridge assembly to thereby discharge the plurality of surgical fasteners retained therein. Upon discharge, the surgical fasteners are driven through the tissue and into the anvil 4012 for formation.
(69) It is also envisioned that the tool assembly 1006 (FIG. 1) may also be adapted for use with any of the other surgical fastener applying apparatus discussed in commonly owned U.S. Pat. Nos. 6,045,560; 5,964,394; 5,894,979; 5,878,937; 5,915,616; 5,836,503; 5,865,361; 5,862,972; 5,817,109; 5,797,538; and 5,782,396, the disclosures of which are hereby incorporated by reference herein in their entirety.
(70) In additional embodiments of the present disclosure, the surgical fastener applying apparatus may include a plurality of cam bars for interacting with the pushers to deploy the surgical fasteners. For example, the surgical fastener applying apparatus disclosed in U.S. Pat. No. 5,318,221, the disclosure of which is hereby incorporated by reference herein, in its entirety, has a cam bar adapter that holds a plurality of cam bars and a knife. A channel is advanced through operation of the handle of the apparatus, which drives the cam bars and knife forward. A clamp tube that surrounds the proximal end of the anvil is advanced to clamp the anvil and cartridge together. In another example, the surgical fastener applying apparatus disclosed in U.S. Pat. No. 5,782,396, the disclosure of which is hereby incorporated by reference herein, in its entirety, has an actuation sled. An elongated drive beam is advanced distally through operation of the handle of the apparatus, driving the actuation sled forward. The distal end of the drive beam engages the anvil and the channel that supports the cartridge as the drive beam travels distally, to deploy the staples and clamp the anvil and cartridge together.
(71) In a further embodiment of the present disclosure, FIG. 16 shows a cross-sectional view of a tool assembly 2004 having an anvil member 2100 and cartridge assembly 2200. The fastener retention slots 2216 in the outer rows are sized to allow the surgical fasteners 100 to exit the slots 2216 at an angle. The anvil member 2100 has a plurality of forming recesses 2316 for each slot 2216, to ensure formation of the fastener at one or more angled positions with respect to the vertical axis “Z-Z” of the surgical fastener cartridge 2202. The fastener retention slots 2216 in the inner rows, adjacent the longitudinal knife slot 2217 of the surgical fastener cartridge 2202, are sized so that the surgical fasteners 100 exit the retention slots 2216 in a substantially vertical orientation, i.e., along the vertical axis “Z-Z,” or at a smaller angle with respect to the vertical axis “Z-Z,” as compared to the surgical fasteners 100 in the outer rows of fastener retention slots 2216. The surgical fasteners 100 in each row of fastener retention slots 2216 may be the same size, or alternatively, the surgical fasteners 100 in the in the outer rows of fastener retention slots 2216 may be larger in size when compared to the surgical fasteners 100 in the inner rows of fastener retention slots 2216. For example, the surgical fasteners 100 in the in the outer rows of fastener retention slots 2216 may have longer leg lengths when compared to those of the surgical fasteners 100 in the inner rows of fastener retention slots 2216. The tendency of tissue to extrude in a laterally outward direction with respect to the cartridge body 2202 will encourage the surgical fasteners 100 to angle outwardly, as shown in FIG. 16.
(72) In certain embodiments, the anvil member 2100 is comprised of a plurality of plates 2130, each having defined therein forming recesses 2316, as shown in FIGS. 17 and 18. The plates 2130 are attached to one another so as to form the anvil member 2100, e.g., via lamination. The forming recesses 2316 may be arranged so that more than one forming recess 2316 corresponds to a fastener retention slot 2216. In this way, a surgical fastener 100 exiting a fastener retention slot 2216 will be directed into, and formed by, one of the forming recess 2316, whether the surgical fastener 100 exits the fastener retention slot 2216 in a substantially vertical, or angled, fashion.
(73) The above description, disclosure, and figures should not be construed as limiting, but merely as exemplary of particular embodiments. It is to be understood, therefore, that the disclosure is not limited to the precise embodiments described, and that various other changes and modifications may be effected by one skilled in the art without departing from the scope or spirit of the disclosure. Additionally, those skilled in the art will appreciate that the elements and features illustrated or described in connection with one embodiment can be combined with those of another, and that such modifications and variations are also intended to be included within the scope of the present disclosure.
